Enzastaurin Granted Orphan Drug Status for Treatment of Diffuse Large B-Cell Lymphoma (DLBCL)

Enzastaurin Granted Orphan Drug Status for Treatment of Diffuse Large B-Cell Lymphoma (DLBCL)

March 27, 2007

Oral Agent Designed to Address High Incidence of Relapse in
DLBCL Population


    INDIANAPOLIS, March 27 /Xinhua-PRNewswire/ -- Eli Lilly
and Company announced to-day that the European Medicines
Agency (EMEA) has granted enzastaurin, an in-vestigational,
multi-targeted, oral, cancer agent, orphan drug designation
for the treatment of diffuse large B-cell lymphoma (DLBCL).
 Although rare, DLBCL is the most common sub-type of
non-Hodgkin's lymphoma (NHL) of which approxi-mately 50% of
high-risk patients (high-risk is defined as having an
Interna-tional Prognostic Index score of 3-5) relapse
within three years after receiv-ing first line therapy. (1)
An International Prognostic Index score (IPI) is a criteria
determined by a patient's oncologist.

    Enrollment into a Phase III clinical trial studying
enzastaurin is currently underway. The PRELUDE (Preventing
Relapse in Lymphoma Using Daily Enzastaurin) trial is a
randomized, placebo controlled study in DLBCL patients at
high risk for relapse who have achieved remission following
first-line therapy.  Specifically, enzastaurin is being
investigated as a maintenance therapy to prevent disease
relapse. The study will compare the efficacy, safety and
tolerability of enzastaurin, taken orally for up to three
years, versus placebo.  The study is expected to enroll 459
patients across 100 sites worldwide.  The primary endpoint
of the study will be overall disease-free survival.  More
details on the study design, inclusion criteria and how to
en-roll are available at http://www.lillytrials.com or by
visiting http://www.clinicaltrials.gov . 

    "In recent years, there has been progress in
improving first-line thera-pies that help more patients
achieve remission.  However, our objective with enzastaurin
is to develop an agent that may fill this important
therapeutic need -- the ability to keep DLBCL patients in
remission," said Richard Gaynor, M.D., vice president,
cancer research and global oncology platform leader for Eli
Lilly and Company. 

    Enzastaurin 

    Enzastaurin is an oral, serine threonine kinase
inhibitor which selec-tively targets the PKCBeta and
PI3/AKTsignaling pathways. By blocking these key pathways
frequently over-expressed in a wide variety of cancers,
en-zastaurin suppresses tumor cell proliferation, induces
tumor cell death and inhibits tumor-induced angiogenesis.
Treatment has been well tolerated with minimal drug-related
toxicity.  Enzastaurin administration is associated with
fatigue, diarrhea, nausea, decreased platelets, cough,
vomiting, transaminase elevation, dyspnea, peripheral
edema, and dizziness.  Further testing in Phase III versus
a placebo will provide us with a more complete look at the
side ef-fect profile for enzastaurin. In addition to DLBCL,
enzastaurin is also being studied in other tumor types
including breast, colon, lung, ovarian and pros-tate
cancers.

    Non-Hodgkin's Lymphoma and Diffuse Large B-cell
Lymphoma

    Non-Hodgkin's lymphoma is the most common cancer of the
lymphatic system, the body's defense mechanism against
infection and disease. Once considered rare, non-Hodgkin's
lymphoma rates have increased 83 percent in the past 25
years.  NHL is now considered the fifth most common of all
cancers, with more than 56,000 new diagnoses made in the
United States each year and 46,000 new cases each year in
the European Union. 

    Diffuse large B-cell lymphoma (DLBCL) describes the
appearance of the ma-lignant B-cells in the lymphoma and it
is the most frequently occurring his-tologic subtype in
adults, constituting approximately 31% of all new diagnoses
(Armitage and Weisenburger 1998).  The vast majority of
relapses occur in the first 2 years after therapy
(Cabanillas et al. 1992).  Life expectancy of un-treated
patients with DLBCL is very short.

    Orphan Medical Product Designation in the European
Union  

    Orphan medicinal products are for diagnosing,
preventing or treating life-threatening or very serious
conditions that are rare and affect not more than 5 in
10,000 persons in the European Union. 

    About Lilly Oncology, a division of Eli Lilly and
Company

    For more than four decades, Lilly Oncology has been
collaborating with cancer researchers to deliver innovative
treatment choices and valuable pro-grams to patients and
physicians worldwide.  Inspired by the courageous pa-tients
living with cancer, Lilly Oncology is providing treatments
that are considered global standards of care and developing
a broad portfolio of novel targeted therapies to accelerate
the pace and progress of cancer care.  

    About Eli Lilly and Company

    Lilly, a leading innovation-driven corporation, is
developing a growing portfolio of first-in-class and
best-in-class pharmaceutical products by ap-plying the
latest research from its own worldwide laboratories and
from col-laborations with eminent scientific organizations.
Headquartered in Indianapo-lis, Ind., Lilly provides answers
-- through medicines and information - for some of the
world's most urgent medical needs. 

    P-LLY

    This press release contains forward-looking statements
about the potential of the investigational compound
enzastaurin (LY317615) and reflects Lilly's current
beliefs. However, as with any pharmaceutical product under
develop-ment, there are substantial risks and uncertainties
in the process of develop-ment and regulatory review. There
is no guarantee that the product will re-ceive regulatory
approvals, or that the regulatory approval will be for the
indication(s) anticipated by the company. There is also no
guarantee that the product will prove to be commercially
successful. For further discussion of these and other risks
and uncertainties, see Lilly's filings with the United
States Securities and Exchange Commission.  Lilly
undertakes no duty to update forward-looking statements.

    (1) Shen, Laurie H and col. 2007. The Revised
International Prognostic In-dex (R-IPI) is a better
predictor of outcome than the standard IP for patients with
diffuse large B cell Lymphoma treated with RCHOP. Blood 109
(N5):1857, 1861.

    (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )


    For more information, please contact:

     Christine Van Marter
     Eli Lilly and Company
     Tel:   [phone]
     Email: [e-mail]